Identity
- Trade Name
- Infinity EUDAMEDFDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, single-use FDA UDI
- Device Name
- Orthopedic, Non-active, Reamer, Disposable, Infinity EUDAMEDInfinity Retro-Reamer, 7.5 mm FDA UDI
- Model / Reference
- KRR075 EUDAMEDFDA UDI
- Description
- Infinity Retro-Reamer, 7.5 mm FDA UDI
Identifiers
- Catalog Number
- KRR075 FDA UDI
- Primary DI / UDI-DI
- 20845854083496 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20845854083496 EUDAMED
- FDA Product Code
- GFG FDA UDI
- EMDN Code
- P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES EUDAMED
- GMDN Term
- Bone-resection orthopaedic reamer, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Infinity by Conmed Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20845854083496 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 0b222ac6-9f7f-4b85-a091-924087ab9c73 61 fields · synced May 30, 2026
- FDA UDI 3c449fc3-e80f-45d9-bda9-a930b0aa31fe 36 fields · synced May 30, 2026